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Good News for OncoGenex on Custirsen

OncoGenex Pharmaceuticals, Inc. (OGXI) received encouraging news when the independent data monitoring committee (:IDMC) recommended the continuation of the company’s phase III study (SYNERGY: n~1,023) on custirsen. The IDMC made its recommendation after completion of interim efficacy analysis of the data from the phase III trial.

The study is evaluating the survival benefit of the candidate, in combination with first-line Sanofi’s (SNY) Taxotere (docetaxel), in metastatic castrate-resistant prostate cancer (:CRPC) patients. OncoGenex expects final survival data from the study by mid 2014.

OncoGenex and partner Teva Pharmaceutical Industries, Ltd. (TEVA) are blinded to all data from the SYNERGY trial. We note that in Dec 2009, OncoGenex entered into a collaboration agreement with Teva for the development and global commercialization of custirsen.

OncoGenex is also conducting the phase III AFFINITY study to evaluate the overall survival benefit of custirsen plus Sanofi’s Jevtana (cabazitaxel) as second-line chemotherapy in patients with metastatic CRPC. OncoGenex expects to complete enrollment by the end of 2014.

Custirsen is in another phase III study – ENSPIRIT –conducted in patients with advanced or metastatic non-small cell lung cancer (:NSCLC). The study is evaluating the potential survival benefit of custirsen plus Taxotere as second-line chemotherapy.

Custirsen received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with Taxotere and also for the second-line treatment of advanced NSCLC when combined with Taxotere in patients with disease progression.